Trial record 1 of 2 for:    dimebon CONCERT
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Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil (CONCERT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00829374
First received: January 23, 2009
Last updated: August 27, 2012
Last verified: August 2012

January 23, 2009
August 27, 2012
March 2009
December 2011   (final data collection date for primary outcome measure)
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, Weeks 12, 26, 39 and 52 ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) [ Time Frame: Baseline, Weeks 13, 26, 39, and 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829374 on ClinicalTrials.gov Archive Site
  • Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Euro Quality of Life 5 (EQ-5D) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Baseline, Weeks 12, 26,39 and 52 ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Weeks 13, 26, 39 and 52 ] [ Designated as safety issue: No ]
  • Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Baseline, Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • Euro Quality of Life 5 (EQ-5D) [ Time Frame: Baseline, Weeks 26 and 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Dimebon
    5 mg orally three times daily
  • Drug: Dimebon
    20 mg orally three times daily
  • Drug: Placebo comparator
    Placebo orally three times daily
  • Experimental: 1
    Dimebon, 5 mg orally three times daily
    Intervention: Drug: Dimebon
  • Experimental: 2
    Dimebon, 20 mg orally three times daily
    Intervention: Drug: Dimebon
  • Placebo Comparator: 3
    placebo orally three times daily
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1003
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild-to-moderate Alzheimer's disease
  • Probable AD (DSM-IV-TR)
  • MMSE score between 12 and 24, inclusive
  • Stable on donepezil for at least 6 months

Exclusion Criteria:

  • Other causes of dementia
  • Major structural brain disease
  • Unstable medical condition or significant hepatic or renal disease
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Finland,   France,   Germany,   Italy,   New Zealand,   Sweden,   United Kingdom
 
NCT00829374
DIM18
Yes
Medivation, Inc.
Medivation, Inc.
Pfizer
Not Provided
Medivation, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP